Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation (MITRA-FR)

Civil Hospices of Lyon

Status and phase: Unknown; Phase 3

Conditions: Cardiovascular Diseases

Treatments: Device: Percutaneous MitraClip Device Implantation; Other: control

Study type: Interventional

Funder types: Other

Identifiers

NCT01920698

2013-A00464-41 (Other Identifier)

2013.798

Details and patient eligibility

About

The objective of this trial is to compare the safety, the efficacy and the cost-effectiveness of 2 therapeutic strategies (optimal standard of care therapy alone versus percutaneous MitraClip procedure and optimal standard of care therapy) in patients with severe secondary mitral regurgitation.

This trial is a French, multicenter and randomized trial. Patients enrolled will be clinically followed for 2 years (phone call at 1 month, clinical visit at 6 months, 12 months and 24 months).

Enrollment: 288 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years old
• Severe secondary mitral regurgitation characterised, according to the European guidelines and recommendations, by a regurgitant volume>30 mL/beat or an effective regurgitant orifice>20 mm².
• New York heart Association Class≥ II.
• Left ventricular ejection fraction between 15% and 40%
• Minimum of 1 hospitalization for heart failure within 12 months preceding randomization
• Optimal standard of care therapy for heart failure according to investigator.
• Not eligible for a mitral surgery intervention according to the Heart Team.
• Willingness to participate in the study and signed written informed consent
• Affiliation to a health insurance system or a similar system

Exclusion criteria

• Eligible for a mitral surgery intervention according to the Heart Team.
• Primary mitral regurgitation.
• Myocardial infarction or coronary bypass grafting surgery within three months prior to randomization.
• Cardiac resynchronization therapy within three months prior to randomization.
• Cardioversion within three months prior to randomization
• Transcatheter aortic valve implantation within three months prior to randomization
• Need for any cardiovascular surgery (including registration on cardiac transplant list).
• Coronary angioplasty within one month prior to randomization.
• Previous surgical mitral valve repair.
• Renal replacement therapy.
• Active infection requiring current antibiotic therapy.
• Severe hepatic insufficiency.
• Stroke within three months prior to randomization.
• Concurrent medical condition with a life expectancy of less than 12 months.
• Uncontrolled arterial hypertension.
• Hypersensitivity to nitinol.
• Participation to another trial.
• Pregnancy.
• No affiliation to a health insurance system.
• Legal protection measure (guardianship or curatorship)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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288 participants in 2 patient groups

MitraClip Device

Experimental group

Description:

Subjects randomized to the MitraClip Device group will undergo the MitraClip procedure in addition to optimal standard medical therapy.

Treatment:

Device: Percutaneous MitraClip Device Implantation

Control

Other group

Description:

Patients randomized to the Control group will receive optimal therapy alone

Treatment:

Other: control